|Publication number||US7478636 B2|
|Application number||US 11/198,992|
|Publication date||Jan 20, 2009|
|Filing date||Aug 8, 2005|
|Priority date||Aug 8, 2005|
|Also published as||CA2618435A1, CA2618435C, CN101237901A, EP1912692A2, EP1912692B1, US20070028924, WO2007018693A2, WO2007018693A3|
|Publication number||11198992, 198992, US 7478636 B2, US 7478636B2, US-B2-7478636, US7478636 B2, US7478636B2|
|Inventors||Edward B. Madsen, Scott M. Teixeira|
|Original Assignee||Kimberly-Clark Worldwide, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (51), Referenced by (17), Classifications (9), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to a tracheal tube used for mechanical ventilation of a hospital patient, by insertion of the tube into the trachea of the patient. In particular, the present invention relates to a tracheal tube having means for irrigating and/or evacuating contaminated fluids accumulating above the tracheal tube cuff and thereby reducing the risk of such contaminated fluids entering the lungs of the patient.
Tracheal intubation involves the insertion of a tubular device, known as a tracheal tube, into the trachea of a patient. The tracheal tube passes through the trachea and terminates at a position above the carina, anterior to a position between the second and fourth thoracic vertebrate. Gases may then be introduced through the tracheal tube and into the lungs of the patient.
The primary purposes of tracheal intubation, are to mechanically ventilate the patient's lungs, when a disease prevents the patient from normal, breathing induced ventilation, or to apply anesthetic gases during surgical intervention. In order to create enough air pressure to accomplish such mechanical ventilation and to prevent escape of gases past the tube, it is necessary to seal the passageway around the tracheal tube. A seal may be produced by the use of an inflatable cuff formed integrally with and surrounding the tracheal tube. When the tracheal tube has been introduced into the patient's trachea, the inflatable cuff will normally be located about 3 to 5 centimeters above the carina and within the tube-like trachea.
The inflatable cuff is then inflated so as to engage the wall of the trachea and thereby seal the trachea and prevent gases being introduced through the tracheal tube from simply backing up around the tube. While treatment of this sort has proved successful for patients having chronic or acute respiratory diseases, there is a constant risk of several complications.
In particular, many patients receiving tracheal intubation develop pneumonia, resulting from an infection of the lungs, possibly induced by contaminated, pooled fluids entering the trachea and the lungs after bypassing the epiglottis during intubation. The fluids may be in the form of saliva, blood, secretions, food and stomach contents, even medications. The epiglottis normally operates as a valve which selectively closes the entry into the trachea and lungs, to prevent the introduction of secretions and particulate matter. However, when a tracheal tube is in place, the epiglottis is held in an open position, and secretions which would normally be directed away from the trachea and into the digestive system, instead follow the path of the tracheal tube and pool above the inflatable cuff of the tracheal tube.
The greatest risk of such infectious fluids reaching the lungs is aspiration of these fluids past the tracheal tube cuff during the mechanical ventilation episode. An additional risk in particular is when the need for endotracheal intubation ends, the inflatable cuff of the endotracheal tube is deflated so that the endotracheal tube may be withdrawn, the infectious fluids which have accumulated above the inflatable cuff are released and flow freely into the lower airway where bronchitis and pneumonia may rapidly develop.
To overcome these risks, it is known in the prior art to combine a single lumen suction tube with a tracheal tube. The suction tube is joined to the tracheal tube in a suitable manner, the end of the suction tube terminating at a position above the inflatable cuff. The suction tube provides means for suction or evacuation of any pooled secretions which accumulate in the trachea above the inflatable cuff. However, such prior art devices have the disadvantage that use of a single lumen for the suction tube often causes direct suction to be exerted on the tracheal mucosa which may then result in damage to the mucosa.
U.S. Pat. No. 4,840,173 to Porter III, describes an endotracheal tube having a single lumen suction tube merged thereto. In particular, this patent describes a device wherein the suction tube is laminated to the outside of the ventilation tube, so that the suction tube terminates at a position just above the inflatable cuff. The suction tube includes multiple openings which may be used to evacuate secretions which pool above the inflatable cuff. In addition, the inflatable cuff includes a section immediately adjacent to the end of the suction tube that is less flexible than the rest of the inflatable cuff, to insure that the flexible material of the inflatable cuff is not sucked up against the suction tube openings. The endotracheal tube described in the Porter III patent has the disadvantages noted above, that the single lumen suction tube may exert suction on the tracheal mucosa and thereby cause damage to the mucosa. Further, the Porter III device is of a relatively complex design, requiring difficult processing, resulting in expensive production.
U.S. Pat. No. 5,143,062, issued to Peckham, discloses an endotracheal tube comprising a double lumen through which air may be circulated, creating an indirect gentle suction through a suction eye communicating with the distal ends of the lumens, and located at a position proximal to the inflation cuff. This design, however, does not provide adequate suction necessary for aspirating secretions and is easily occluded.
The above noted patent references fail to adequately address the suctioning of secretions which have pooled above the inflatable cuff in a manner that is sufficient to accomplish the task but is not so strong so as to cause damage to the mucosa. Moreover, these references and other conventional endotracheal and tracheal tubes lack the ability to suction both these secretions, even when a patient is turned according to nationally instituted decubitus prevention protocols. That is, they fail to provide alternative suction capabilities in the event the patient is turned or in the event the desired suction lumen is occluded by secretions.
As the background devices fail to disclose a tracheal tube and suction catheter system having these structural characteristics, the need for such a device is apparent. The instant invention addresses this by providing a multilumen tracheal tube and suction catheter system comprising a device that enables the surgical team to direct suctioning to any number of lumens within the tracheal tube.
The present invention improves upon a tracheal tube. In one embodiment, a tracheal tube is provided having a cannula that in turn has a distal end and a proximal end. The cannula has at least one ingression lumen within the cannula having a suction port, the suction port is located distal from the proximal end. Also, the cannula has at least one egression lumen within the cannula in non-communication with the at least one ingression lumen, the at least one egression lumen has a discharge port, the discharge port is also located distal from the proximal end. An inlet for introducing an externally applied therapeutic agent or method is provided in the at least one ingression lumen and an outlet for egress of fluids is provided from the at least one egression lumen. In some embodiments, the cannula is made up of a first wall and a second wall which is concentric to the first wall. The first wall surrounds and defines a ventilation lumen which is adjacent a first surface. The first wall is attached at a second surface to a first surface of the second wall by at least two partitions. The at least one ingression lumen is defined by the second surface of the first wall, the first surface of the second wall, and the first surfaces of the at least two partitions. The at least one egression lumen is defined by the second surface of the first wall, the first surface of the second wall, and the second surfaces of the at least two partitions.
In these embodiments, a collar surrounding the cannula and overlapping each inlet and outlet is provided. The collar is positionable so as to selectively enable and disable fluid communication through each lumen between its port and its inlet or outlet. In some embodiments, two collars are provided. A first collar surrounding the cannula and overlapping the inlet, and a second collar surrounding the cannula and overlapping the outlet is provided. Each collar is positionable so as to selectively enable and disable fluid communication through each lumen between its port and its inlet or outlet. An inflatable cuff surrounding the cannula at the distal end is also provided. The inflatable cuff is adapted to seal the trachea of a patient, the inlet and outlet being proximal to the inflatable cuff.
In another embodiment, a tracheal tube is provided. The tracheal tube has a cannula having a distal end and a proximal end. A plurality of ingression lumens are provided within the cannula, each having a suction port located distal from the proximal end and an inlet located proximal to the proximal end. A plurality of egression lumens are also provided within the cannula, each having a discharge port located distal from the proximal end and an outlet located proximal to the proximal end. Each ingression lumen is maintained in fluid non-communication with each egression lumen so as to minimize cross-contamination of any ingression lumen with any egression lumen. A user manipulable selector is provided for selectively enabling and disabling fluid flow through at least one of an ingression lumen, at least one of an egression lumen, or both. The user manipulable selector may be a rotatable collar rotatably affixed to the cannula and overlapping all of the inlets and outlets. The collar itself would contain a first and a second port therethrough. Rotation of the collar aligns the first port with the inlet of a user selected ingression lumen while automatically aligning the second port with the outlet of a corresponding egression lumen. In many embodiments, a guide is coupled to the cannula. the guide overlaps all of the inlets and outlets and has openings aligned with each inlet and outlet. The collar is rotationally attached to the guide. In each embodiment having a guide, a fluid tight seal is provided between the collar and the guide.
In other embodiments, the user manipulable selector is configured as a first and a second rotatable collar. Each is rotatably affixed to the cannula, the first collar overlapping all of the inlets, and the second collar overlapping all of the outlets. Each collar has at least one port therethrough, wherein rotation of the first collar aligns the at least one port with the inlet of a user selected ingression lumen and rotation of the second collar aligns the at least one port with the outlet of a user selected egression lumen. For this embodiment, a guide may be coupled to the cannula overlapping all of the inlets and outlets. The guide would have openings aligned with each inlet and outlet, the first and second collar would be rotationally attached to the guide. In alternative embodiments, a first and a second guide may be coupled to the cannula. The first guide would for example overlap all of the inlets, and the second guide would overlap all of the outlets. Each guide would be provided with openings aligned with each inlet and outlet respectively. The first collar would be rotationally attached to the first guide and the second collar would be rotationally attached to the second guide.
In each embodiment the ingression lumen would enable the introduction of an externally applied therapeutic agent or method to be introduced into a patient within which the tracheal tube is placed. The egression lumen would enable the suctioning of fluids from a patient within which the tracheal tube is placed. Additionally, a ventilation lumen would be provided. In many embodiments, the ingression and egression lumens would be radially disposed about an outer diameter of the ventilation lumen. An inflatable cuff surrounding the cannula at the distal end adapted to seal the trachea of a patient would be provided in many embodiments as well. The inlets and outlets of the cannulas would be proximal to the inflatable cuff. Moreover an inflation lumen for selectively inflating and deflating the inflatable cuff would be provided.
Other objects, advantages and applications of the present invention will be made clear by the following detailed description of a preferred embodiment of the invention and the accompanying drawings wherein reference numerals refer to like or equivalent structures.
Reference will now be made to the drawings in which the various elements of the present invention will be given numeral designations and in which the invention will be discussed so as to enable one skilled in the art to make and use the invention. It is to be understood that the following description is only exemplary of the principles of the present invention, and should not be viewed as narrowing the pending claims. Those skilled in the art will appreciate that aspects of the various embodiments discussed may be interchanged and modified without departing from the scope and spirit of the invention.
The distal end 18 of tracheal tube 12 is provided with a balloon 30 which, when inflated, engages the walls of trachea 16 to facilitate mechanical ventilation of patient 10 through a connector 32 coupled to a standard tracheal tube adapter 34 at the proximal end 36 of tracheal tube 12. As would be understood by those of skill in the art, air from the ventilating apparatus for patient 10 enters tracheal tube 12 through one leg of the connector 32, and correspondingly, air is returned to the ventilating apparatus from patient 10 through a second leg of the connector.
Looking now to
A plurality of suction ports 40 are provided at desirable locations along the tube 12. In some embodiments, a portion of the suction ports 40 are located above the balloon 30, i.e., between the balloon 30 and the proximal end 36, while another portion are located below the balloon 30, i.e., between the balloon 30 and the distal end 18. Some embodiments may have suction ports 40 on only one side of the balloon 30. Likewise, a plurality of discharge ports 41 are also provided at desirable locations along the tube 12. In some embodiments, a portion of these discharge ports 41 are also located above the balloon 30, while another portion are located below the balloon 30. Similarly, in some embodiments the discharge ports 41 may be located on only one side of the balloon 30.
As shown in
As seen in
Looking in more detail at
Turning now to an alternative embodiment as shown in the cross-sectional view labeled
Looking at each position, P1 through P6, provides one with a better understanding of this particular embodiment of the invention. It may be seen that rotating the collar 38 so that the passages 62 in the conduits 60 are positioned at P1 effectively occludes both passages 62, and as such, no flow into or out of the cannula would take place. Rotating the collar 38 so that the passages 62 in the conduits 60 are positioned at P2 aligns one of the passages 62 with an egression lumen 45, in this case egression lumen 45 d. The second passage 62 is occluded however and not aligned with an ingression lumen. This position enables the operator or medical personnel to suction fluids from the patient 10 without losing suction by having an open pathway through an ingression lumen 44. Rotating the collar 38 to any of positions P3, P4, or P5 aligns the passages 62 in the conduits 60 with; ingression lumen 44 a and egression lumen 45 a, ingression lumen 44 b and egression lumen 45 b, and ingression lumen 44 c and egression lumen 45 c respectively. Any of these orientations enable the operator to introduce fluids into the patient's respiratory system and to suction them out during the same operation. For example, the operator may wish to introduce an antimicrobial solution to reduce the potential for infection. In such instances it may be desirable to introduce the fluid and to suction it out in a relatively short period of time. P6 aligns one of the passages 62 with an ingression lumen 44, in this case egression lumen 44 d. The second passage 62 is occluded however and not aligned with an egression lumen. This position enables the operator or medical personnel to introduce fluids, such as medication, into the patient 10 without immediately suctioning the medicine out of the patient 10. It can be seen on the
The above description provides for a completely occluded position, P1, a suction only position, P2, and an introduction only position, P6, respectively. It should, however, be understood that the devices themselves that perform the suctioning and/or introduction of fluids do not form part of the invention and are thus not depicted. Nevertheless, each of these devices would likely be provided with means to enable or disable them. Additionally, it is not necessary that such devices be connected to either or both of the conduits 60. As such, fluid flow through any of the lumens may be controlled independently by the devices that are connected to either of the two conduits, irrespective of the intended function of the specific lumen. Through this, the embodiment depicted in
Yet another alternative embodiment as shown in
It should be seen in any of the embodiments described above, that by rotating the collar 38 and/or 39 into a desired position, the user or medical personnel is provided with a selectable means with which to add or suction fluids from the patient 10. In some embodiments, the passage or passages 62 within the collar 38 may be configured to access more than one lumen 44 or 45 simultaneously.
Looking finally to
During use, the collar 38, and 39 if provided, would be rotated to the desired position. An indicator 68, for example, such as the one depicted in
As used herein and in the claims, the term “comprising” is inclusive or open-ended and does not exclude additional unrecited elements, compositional components, or method steps.
While various patents have been incorporated herein by reference, to the extent there is any inconsistency between incorporated material and that of the written specification, the written specification shall control. In addition, while the invention has been described in detail with respect to specific embodiments thereof, it will be apparent to those skilled in the art that various alterations, modifications and other changes may be made to the invention without departing from the spirit and scope of the present invention. It is therefore intended that the claims cover all such modifications, alterations and other changes encompassed by the appended claims.
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|U.S. Classification||128/207.15, 128/200.26|
|Cooperative Classification||A61M16/0434, A61M16/0479, A61M1/0043, A61M16/0463, A61M1/0058|
|Aug 8, 2005||AS||Assignment|
Owner name: KIMBERLY-CLARK WORLDWIDE, INC., WISCONSIN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MADSEN, EDWARD B.;TEIXEIRA, SCOTT M.;REEL/FRAME:016880/0498
Effective date: 20050802
|Jul 20, 2012||FPAY||Fee payment|
Year of fee payment: 4
|Jan 13, 2015||AS||Assignment|
Owner name: AVENT, INC., GEORGIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:KIMBERLY-CLARK WORLDWIDE, INC.;REEL/FRAME:034753/0360
Effective date: 20141030
|Apr 6, 2015||AS||Assignment|
Owner name: MORGAN STANLEY SENIOR FUNDING, INC., NEW YORK
Free format text: SECURITY INTEREST;ASSIGNOR:AVENT, INC.;REEL/FRAME:035375/0867
Effective date: 20150227